PolarityTE reveals SEC investigation

PolarityTE

PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws.

The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an SEC filing.

Read the whole story on our sister site, Drug Delivery Business News

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Admedus wins CE Mark for CardioCel 3D, VascuCel products

Admedus

Admedus (ASX:AHZ)  has won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products which use its proprietary Adapt tissue technology, according to a report from ProactiveInvestors.

The Australian company plans to begin the first stage of a commercial launch of the devices in the region later this month, according to the report.

“After our initial positive experience with Adapt we are excited to have the choice of these 3D shaped products that will produce better reconstructions for complex aortic arch repair surgeries,” Dr. Tomasz Mroczek said, according to ProactiveInvestors.

“Obtaining CE Mark approval for the 3D portfolio is a further endorsement of the medical need and effectiveness of our 3D shaped collagen bioscaffold; a world first technology with proven anticalcification properties and zero DNA. Today’s approval of the 3D portfolio in Europe further reinforces the company’s focus on global strategic growth with geographic expansion into key markets and portfolio expansion of Adapt tissue technology products,” CEO Wayne Patterson said, according to the report. “The 3D single piece aortic valve is unique in the industry and forms the backbone of the company’s TAVR developmental project which has been expedited. We have now confirmed that human clinical trials will commence earlier than planned, and the development project has already generated great interest within the global medical community as the Adapt portfolio of products expand from mainly pediatric use to a wider patient population in the future.”

In June 2017, Admedus CEO Wayne Patterson spoke to MassDevice.com about his efforts to shift the company away from trends of overspending and towards profitability.

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Smith & Nephew puts up $660m for Osiris Therapeutics

Smith & Nephew to acquires Osiris TherapeuticsSmith & Nephew (NYSE:SNN) said today that it agreed to put $660 milli0on on the table to acquire Osiris Therapeutics (NSDQ:OSIR) and its regenerative medicine portfolio.

The British orthopedics and wound care giant said the $19-per-share deal is a 37% premium on the 90-day volume-weighted average for OSIR shares. It’s structured as a two-step tender offer, Smith & Nephew said, with Osiris chairman & co-founder Peter Friedli agreeing to commit his 30% stake. The acquisition is slated to close during the second quarter, with the 360 people employed by Osiris joining S&N, that company said.

“Greater presence in the fast-growing regenerative medicine market enhances our portfolio and will help immediately accelerate our wound management business as well as provide longer term innovations in additional channels and indications. We sought out a fast growing portfolio with strong clinical evidence addressing critical needs in the marketplace,” CEO Namal Nawana said in prepared remarks.

“I am immensely proud of the business we have built from our research into advanced regenerative technologies. Smith & Nephew is the best new owner to take these products forward, widening access to more customers and restoring quality of life for more patients,” Friedli added.

Osiris put up sales of $102 million for the nine months ended Sept. 30, 2018 and $36.5 million during last year’s third quarter. Fourth-quarter and full-year results are on tap for March 15, Smith & Nephew said.

The cash-and-debt transaction is expected to add to S&N’s adjusted earnings per share starting next year, with return on invested capital topping the cost of capital three years after closing, the company said.

OSIR shares closed up 0.9% at $18.88 each yesterday. SNN shares, which closed up 0.8% at $38.79, were up 0.7% to $39.04 apiece just before the open today.

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Cellect Biotechnology launches U.S. clinical trial

Cellect Biotechnology (NSDQ:APOP) said it is collaborating with Washington University on a study of its ApoGraft stem cell selection technology for bone marrow transplantations.

This will be the first clinical trial in the U.S. using Tel Aviv, Israel-based Cellect’s ApoGraft, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. The company previously reported positive safety and tolerability data from an ongoing trial that is being performed outside the U.S., and expects to report additional interim results during the first half of 2019.

Get the full story on our sister site, Medical Design & Outsourcing.

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Ortho RTi touts rotator cuff study results at conference

Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage.

The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas.

Get the full story on our sister site, Medical Design & Outsourcing.

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Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds

Aroa Biosurgery, Tela Bio

Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair.

The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said.

With the clearance, the companies said that they will now offer the OviTex RBS devices in the US in sizes up to 20×40 cm, a 150% surface area increase over its currently available offerings.

“We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases. Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.

“The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence. As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions,” Aroa Biosurgery CEO Brian Ward said in a press release.

Last May, Tela Bio and Aroa Biosurgery said they won CE Mark approval in the European Union for the OviTex RBS, which Tela Bio commercially launched in the region.

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PolarityTE registers bone repair product with FDA

PolarityTE updated logoPolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA.

The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells.

Get the full story at our sister site, Drug Delivery Business News.

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Kuros raises $16m for bone-growth protein

Kuros BiosciencesKuros Biosciences (SIX:KURN) said this week that it raised more than $16 million for clinical trial of its bone-growth protein as it expands the commercial footprint for its MagnetOs bone graft substitute.

Proceeds from the CHF 16.1 million round are earmarked for a Phase II trial of the Fibrin-PTH protein in spinal fusion procedures and for the commercialization of MagnetOs, which won 510(k) clearance from the FDA in August 2017 and CE Mark approval in the European Union in May. Kuros won CE Mark approval in the European for its Neuroseal dural sealant in June 2017.

The Zurich-based company said it plans to launch the study during the second quarter of 2019, with interim data due by the second half of 2020.

“We have made excellent progress on our new course in 2018 and have a strong team in place to take the company forward. The recent capital raise adds to those solid foundations and allows us to build on that success. The first sales of MagnetOs are a realization of the hard work and dedication the Kuros team has put in and we are now focusing on the commercial roll-out, which is proceeding well. On top of that, we are pushing on with the exciting Fibrin-PTH program. Largely de-risked in successful trauma trials, it targets an important medical need in spinal fusion, which represents a significant commercial opportunity,” CEO Joost de Bruijn said in prepared remarks.

$1 = CHF 0.991442

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MiMedx escapes Osiris trade theft suit

MiMedx, Osiris

MiMedx (NSDQ:MDXG) enjoyed a rare spot of good news when a federal judge in Maryland this week dismissed a trade theft and breach-of-contract lawsuit brought by Osiris Therapeutics over MiMedx’s  Stability Biologics acquisition.

Columbia, Md.-based Osiris said it inked a distribution deal back in 2013 to have Stability sell a pair of its products through the end of 2015. But after MiMedx paid $10 million for Stability in January 2016, it allegedly gained access to Osiris trade secrets and fostered a series of events leading to $6.8 million in losses for Osiris.

(In an about-face in August 2017, MiMedx agreed to sell Stability back to its original owners; that sale closed last October.)

The lawsuit, filed in April in the U.S. District Court for Maryland, alleged that MiMedx held on to Osiris inventory worth $2.2 million, plus $1.3 million in pre-paid commissions, and directed Stability not to pay another $2.9 million allegedly owed under a payment plan; Osiris allegedly incurred another $321,000 in legal fees from its attempt to recoup its losses in arbitration.

MiMedx filed a motion to dismiss for lack of jurisdiction. In a Dec. 11 ruling, Judge Catherine Blake ruled that Osiris failed to prove either general or specific jurisdiction in the case.

“None of MiMedx’s alleged contacts with Maryland – which, even by Osiris’s characterization are limited to the acquisition of a subsidiary that owed debts to a Maryland corporation and the operation of a single tissue bank in-state – suffice to give rise to general jurisdiction,” Blake wrote.

“Osiris improperly merges Stability’s contacts with MiMedx’s contacts,” she wrote. “MiMedx’s only contact with Maryland is its distribution of amniotic tissue through a Maryland tissue bank. … [T]his contact is insufficient to support specific jurisdiction in Maryland. “

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Shareholders approve Avista, Organogensis tie up

Avista Capital Partners, Organogensis

Private equity firm Avista Healthcare Public Acquisition Corp. yesterday approved its merger with regenerative medicine company Organogenesis.

The merger won approval yesterday at separate special meetings of shareholders for both companies, Canton, Mass.-based Organogenesis said.

As part of the deal, Avista invested a total of $92 million in the combined company, Organogenesis said. Avista also said it plans to deregister in the Cayman Islands and incorporate in Delaware, according to an SEC filing.

The company is slated to be run by Organogenesis’ existing management team, led by CEO Gary Gillheeney Sr., the company said in a press release.

“We are delighted to have completed this transaction and look forward to capitalizing on Tom Dean and Avista’s strategic expertise as Organogenesis uses the capital from this investment to execute on its compelling growth objectives and continues to deliver its customers a versatile product portfolio to substantially improve the lives of their patients,” Gillheeney said in a press release.

Organogensis is a regenerative medicine company producing devices for wound care, surgical and the sports medicine markets, Avista said. The company has over 600 employees globally.

“We are pleased to have closed this transaction with Organogenesis and look forward to a very successful partnership. Organogenesis is an ideal partner for Avista, given its leading position in the rapidly accelerating regenerative medicine sector, numerous growth opportunities and demonstrated ability to execute on product development and commercialization capabilities. Collectively, we will work to create tremendous value for Organogenesis’ patients, investors, employees and key stakeholders,” Avista co-CEO & managing partner Thompson Dean said in a press release.

The companies originally announced the acquisition in August.

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